PGR2023-00043 - Intas Pharmaceuticals et al. v. Atossa Therapeutics Inc

Details
PATENT NUMBER
11572334 Medical
APPL. NUMBER
17580428
PETITIONER
Intas Pharmaceuticals
Intas Pharmaceuticals Ltd
Intas Biopharmaceuticals Ltd
Large Operating Company
PATENT OWNER
Atossa Therapeutics Inc
Operating Company
STATUS
Final Written Decision
FILING DATE
2023-08-18
INSTITUTION DATE
2024-01-31
TERMINATION DATE
2025-01-29
PET. COUNSEL
McAndrews, Held & Malloy, Ltd.
Mcandrews IP
P.O. COUNSEL
DLA Piper LLP US
DLA Piper LLP
AUTHOR JUDGE
Timeline
Petition
Notice of Filing Date
Preliminary Response
Institution Decision
Final Decision
Aug
Sep
Oct
Nov
Dec
2024
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
2025
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
2026
Docket
Paper No.
Date
Party
Type
Name
12023-08-18PetitionerPetitionPetition : as filed
22023-08-18PetitionerPower of AttorneyNotice : Power of Attorney
10012023-08-18PetitionerUSPN 11,572,334
10022023-08-18PetitionerFile history of USPN 11,572,334
10032023-08-18PetitionerUSPN 9,333,190 (Ahmad)
10042023-08-18PetitionerWO2017/70651 (Liu)
10052023-08-18PetitionerWO 2012/050263 (Song)
10062023-08-18PetitionerAhmad, Endoxifen, a New Cornerstone of Breast Cancer (Ahmad 2010)
10072023-08-18PetitionerAhmad, Endoxifen for breast cancer (Ahmad 2012)
10082023-08-18PetitionerCole, Enteric coated HPMC (2002) (Cole)
10092023-08-18PetitionerKu, Performance qualification (2010) (Ku)
10102023-08-18PetitionerBenameur, Capsule Technology (Benameur)
10112023-08-18PetitionerStegemann, Hard gelatin capsules (2002) (Stegemann)
10122023-08-18PetitionerExcerpts of Handbook of Pharmaceutical Excipients
10132023-08-18PetitionerOffice Action dated 2/25/2020 from 16/641,985
10142023-08-18PetitionerPrescribing Information for Zonalta
10152023-08-18PetitionerUSP 711
10162023-08-18PetitionerBeasley (2015)
10172023-08-18PetitionerEvans (1988)
10182023-08-18PetitionerAhmad, Endoxifen (Ahmad 2016)
10192023-08-18PetitionerMilroy (2018)
10202023-08-18PetitionerExpert Declaration of Jason McConville, Ph.D.
32023-08-30BoardNotice of Filing DateNotice: Notice filing date accorded
52023-09-08Potential Patent OwnerMandatory NoticeNotice : Mandatory Notice
62023-09-08Potential Patent OwnerPower of AttorneyNotice : Power of Attorney
72023-11-30Potential Patent OwnerPreliminary ResponsePatent Owner's Preliminary Response
82023-11-30Potential Patent OwnerOtherMotion for Pro Hac Vice Admission (Susan M. Krumplitsch)
20012023-11-30Potential Patent OwnerExpert Declaration of Stephen Graham Davies, D. Phil. (“Davies Decl.”)
20022023-11-30Potential Patent OwnerElkins et al., Characterization of the isomeric configuration
20032023-11-30Potential Patent OwnerU.S. Patent No. 11,261,151 (“’151 patent”)
20042023-11-30Potential Patent OwnerExcerpt of ’151 Patent File History - IDS Filings, Receipts, List Considered
20052023-11-30Potential Patent OwnerExcerpt of ’151 Patent File History - Liu (“’985 File History 2”)
20062023-11-30Potential Patent OwnerExcerpt of ’151 Patent File History - FOA and NOA (“’985 File History 3”)
20072023-11-30Potential Patent OwnerIntl. Pub. No. WO 2010/135703A2 by Ahmad et al.
20082023-11-30Potential Patent OwnerIntl. Pub. No. WO 2009/032699A1 by Bortz et al.
20092023-11-30Potential Patent OwnerIntl. Pub. No. WO 2009/120999A2 by Kushner et al.
20102023-11-30Potential Patent OwnerExcerpt of File History for U.S. Patent 9,333,190 - Office Actions, Responses, Declarations, and Allowance
20112023-11-30Potential Patent OwnerAli et al., “Endoxifen is a new potent inhibitor of PKC: A potential therapeutic agent
20122023-11-30Potential Patent OwnerInternational Counsel for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
20132023-11-30Potential Patent OwnerStephen Graham Davies, D. Phil. Curriculum Vitae
20142023-11-30Potential Patent OwnerCenter for Drug Evaluation and Research, FDA Guidance Document, “Development of New Stereoisomeric Drugs,”
20152023-11-30Potential Patent OwnerLv et al., “Synthesis of mixed (E,Z)-, (E)-, and (Z)-norendoxifen with dual aromatase inhibitory and estrogen receptor modulatory activities,”
20162023-11-30Potential Patent OwnerBuchanan et al., “Solubilization and Dissolution of Tamoxifen-Hydroxybutenyl Cyclodextrin Complexes,” J. Pharm. Sciences, 95(10):2246-2255 (2006) (“Buchanan”)
20172023-11-30Potential Patent OwnerGupta et al., “Salts of Therapeutic Agents: Chemical, Physicochemical, and Biological Considerations,” Molecules, 23:1719 (2018) (“Gupta”)
20182023-11-30Potential Patent OwnerJacques et al., Enantiomers, Racemates, and Resolutions (1981) (“Jacques”)
20192023-11-30Potential Patent OwnerSusan M. Krumplitsch Declaration in Support of Motion for Pro Hac Vice
92023-12-11BoardOtherOrder: Granting Patent Owners Motion for Admission Pro Hac Vice of Susan M. Krumplitsch 37 C.F.R. sec. 42.10
102023-12-26PetitionerReplyPetitioner's Reply to Patent Owner's Preliminary Response
112024-01-31BoardInstitution DecisionInstitution Decision: Grant
122024-01-31BoardOtherSCHEDULING ORDER
132024-03-12Patent OwnerOtherPatent Owner's Notice of Deposition of Jason McConville, Ph.D.
142024-04-24Patent OwnerResponsePatent Owner Response to Petition
20202024-04-24Patent OwnerExpert Declaration of Stephen Graham Davies, D. Phil. in Support of Patent Owner’s Response (“Davies POR Decl.”)
20212024-04-24Patent OwnerDeposition Transcript of Jason T. McConville, Ph.D. taken on April 12, 2024, in Intas Pharmaceuticals Ltd. v. Atossa Therapeutics, Inc., PGR2023-00043 (“McConville Tr.”)
20222024-04-24Patent OwnerExcerpt of File History for U.S. Patent 9,333,190 – Original Filed Application, Office Actions, Responses, Appeal of Examiner’s Decision, Declarations, and Allowance (“Ahmad File History Excerpt 2”)
20232024-04-24Patent OwnerPrescribing Information for Nolvadex (tamoxifen citrate tablets)
20242024-04-24Patent OwnerPrescribing Information for Soltamox (tamoxifen citrate solution)
20252024-04-24Patent OwnerPrescribing Information for Evista (raloxifene hydrochloride tablets)
20262024-04-24Patent OwnerPrescribing Information for Fareston (toremifene citrate tablets)
152024-06-10PetitionerOtherPetitioner's Notice of Deposition of Stephen Graham Davies, D. Phil.
162024-07-17PetitionerReplyPetitioner's Reply
10222024-07-17PetitionerFauq (2010)
10232024-07-17PetitionerFauq (2010) Supplementary Material
10242024-07-17PetitionerNMR Spectra
10252024-07-17PetitionerMilroy Supplementary Material
10262024-07-17PetitionerMajee (2017)
10272024-07-17PetitionerMarzorati (2015)
10282024-07-17PetitionerAl-Tabakha (2010)
10292024-07-17PetitionerHonkanen (March 2004)
10302024-07-17PetitionerExpert Declaration of Ron Bihovsky, Ph.D.
10312024-07-17PetitionerReply Expert Declaration of Jason McConville, Ph.D.
10322024-07-17PetitionerHPE Excerpts
172024-07-29Patent OwnerOtherPatent Owner's Notice of Deposition of Dr. Jason McConville
182024-07-29Patent OwnerOtherPatent Owner's Notice of Deposition of Dr. Ron Bihovsky
192024-08-05PetitionerMandatory NoticePetitioner's Updated Mandatory Notice Information
202024-08-27Patent OwnerOtherJoint Stipulation to Modify Due Date 3
30012024-09-04BoardExhibit 3001
212024-09-06Patent OwnerSur-ReplyPatent Owner's Sur-Reply to Petition for Post-Grant Review
20272024-09-06Patent OwnerDeposition Transcript of Ron Bihovsky, Pd.D. taken on August 14, 2024
20282024-09-06Patent OwnerDeposition Transcript of Jason T. McConville, Ph.D. taken on August 15, 2024
20292024-09-06Patent OwnerSupplemental Declaration of Stephen Graham Davies, D. Phil. in Support of Patent Owner’s Sur-Reply
222024-09-13PetitionerOtherPetitioner's Amended Notice of Deposition of Stephen Graham Davies, D. Phil.
232024-09-18Patent OwnerOtherPatent Owner's Request for Oral Argument
242024-09-18PetitionerOtherPetitioner's Request for Oral Argument
252024-09-25BoardOtherOrder Setting Oral Argument
262024-09-30PetitionerOtherPetitioner's Observations on the Cross-Examination of Stephen G. Davies, D. Phil.
10332024-09-30PetitionerDr. Davies Cross-Examination Transcript, 9/18/2024
30022024-10-15BoardEx. 3002 Request for authorization to file a Response
272024-10-21Patent OwnerOtherPatent Owner's Response to Petitioner's Observations on the Cross-Examination of Dr. Stephen G. Davies
282024-10-22BoardOtherLEAP Practitioner Request and Verification Form (Petitioner)
292024-10-29PetitionerOtherJoint Identification of Objections to Oral Argument Demonstratives
302024-10-30Patent OwnerExhibitPatent Owner's Updated Exhibit List
312024-10-30PetitionerExhibitPetitioner's Updated Exhibit List
10342024-10-30PetitionerPetitioner's Oral Argument Demonstratives
20302024-10-30Patent OwnerPatent Owner's Hearing Demonstratives
30032024-11-04BoardEx. 3003
322024-11-08Patent OwnerPower of AttorneyPatent Owner's Power of Attorney
332024-11-08Patent OwnerMandatory NoticePatent Owner's Mandatory Notices Pursuant to 37 C.F.R. § 42.8
342024-11-21BoardOtherOther: Hearing transcript
352025-01-08Patent OwnerPower of AttorneyPatent Owner's Updated Power of Attorney
362025-01-08Patent OwnerMandatory NoticePatent Owner's Updated Mandatory Notices
30042025-01-08BoardEx. 3004
372025-01-29BoardFinal DecisionDetermining All Challenged Claims Unpatentable 35 U.S.C. § 328(a)
Grounds Asserted

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